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Last Updated: June 24, 2021

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VISTOGARD Drug Profile


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When do Vistogard patents expire, and what generic alternatives are available?

Vistogard is a drug marketed by Wellstat Therap and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and seventy-five patent family members in twenty-one countries.

The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.

DrugPatentWatch® Generic Entry Outlook for Vistogard

Vistogard was eligible for patent challenges on September 4, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 10, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VISTOGARD
International Patents:175
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 64
Patent Applications: 191
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in VISTOGARD?VISTOGARD excipients list
DailyMed Link:VISTOGARD at DailyMed
Drug patent expirations by year for VISTOGARD
DrugPatentWatch® Estimated Generic Entry Opportunity Date for VISTOGARD
Generic Entry Date for VISTOGARD*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for VISTOGARD

US Patents and Regulatory Information for VISTOGARD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VISTOGARD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 2017/033 Ireland   Try Before You Buy PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470 LUC00036 Luxembourg   Try Before You Buy PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470 2017C/028 Belgium   Try Before You Buy PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470 17C1028 France   Try Before You Buy PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470 CA 2017 00036 Denmark   Try Before You Buy PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
1849470 300889 Netherlands   Try Before You Buy PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470 1790063-0 Sweden   Try Before You Buy PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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